(22 days)
Not Found
No
The summary describes a software upgrade for a ventilator that facilitates data transfer between devices, with no mention of AI or ML algorithms for decision-making or analysis.
Yes
The document explicitly states that the Esprit ventilator is intended for providing "continuous or intermittent ventilatory support to adult and pediatric patients," which is a therapeutic function. The NICO-Esprit Interface is a software upgrade to this therapeutic device.
No
The device is described as a mechanical ventilator for providing ventilatory support, not for diagnosing conditions. The NICO-Esprit Interface facilitates communication of parameters between the ventilator and a monitor, which is for information transfer, not for diagnosis.
No
The device is described as a software upgrade to a mechanical ventilator, which is a hardware device. The software facilitates communication between the ventilator and another hardware device (NICO Monitor). The summary also mentions safety testing per IEC 60601-1-2 and UL 2601, which are standards for electrical medical equipment, indicating hardware is involved.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Esprit ventilator is for providing ventilatory support to patients. This is a life support function performed directly on the patient.
- Device Description: The device description focuses on the ventilator's function and the software interface for communication with a NICO monitor (which measures respiratory parameters). Neither of these activities involves testing samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The device is a medical device used for respiratory support, which is a therapeutic and monitoring function performed in vivo (within the body).
N/A
Intended Use / Indications for Use
The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
Prescription Use XX (Per 21 CFR 801 subpart D) AND/OR Over-the-counter Use (21 CFR 807 Subpart C)
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
The NICO-Esprit Interface is a software upgrade to the Esprit Ventilator, which allows the bi-directional communication of the devices to facilitate the transfer of NICO parameters to the Esprit Ventilator as well as the transfer of a patient's breath type information and FiO2 from the Esprit to the NICO Monitor.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric patients
Intended User / Care Setting
qualified medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Safety testing was conducted per the applicable sections of IEC 60601-1-2 and UL 2601. Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with NICO-Esprit Interface have been met.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K981072, K001208, K023350, K034040, K964543, K030886
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
JUN 1 8 2004
Special 510(k): Device Modification Esprit Ventilator with NICO-Esprit Interface
510(k) SUMMARY 6
| Company
Information: | Respironics, California Inc.
2271 Cosmos Court
Carlsbad, CA. 92009 | |
|-------------------------|--------------------------------------------------------------------------|-------------------------------------|
| Contact: | Mary Funk, Regulatory Affairs Project Manager | |
| | Phone Number: (760) 918-7328
Fax Number: (760) 918-0169 | |
| Date Prepared: | May 11, 2004 | |
| Product Name: | Esprit Ventilator with the NICO-Esprit Interface | |
| Common Name: | Ventilator | |
| Classification: | Class II
Continuous Ventilator (per 21 CFR 868.5895) | |
| Predicate
Devices: | Respironics Esprit Ventilator | K981072 K001208
K023350, K034040 |
| | Infrasonics Adult Star Ventilator | K964543 |
| | NICO Monitor | K030886 |
Device Description: 6.1
The NICO-Esprit Interface is a software upgrade to the Esprit Ventilator, which allows the bi-directional communication of the devices to facilitate the transfer of NICO parameters to the Esprit Ventilator as well as the transfer of a patient's breath type information and FiO2 from the Esprit to the NICO Monitor.
6.2 Intended Use:
The addition of the NICO-Esprit Interface has not changed the original intended use as described in the labeling. The Esprit ventilator is a microprocessor controlled, electrically powered, mechanical ventilator. It is intended for use by qualified medical personnel in providing continuous or intermittent ventilatory support to adult and pediatric patients as prescribed by a physician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
Esprit is not intended for use in the presence of flammable anæsthetics. Esprit is a prescription use device that is intended for sale by or on the order of a physician.
Technological Characteristics: 6.3
The Esprit ventilator does not incorporate any new technological characteristics with the addition of the NICO-Esprit Interface Option.
1
Special 510(k): Device Modification Esprit Ventilator with NICO-Esprit Interface
Determination of Substantial Equivalence: 6.4
Ventilator with NICO-Esprit Interface has similar performance The Esprit characteristics, the same intended use and the same environment of use and patient populations as the currently marketed predicate devices. The labeling and instructional information, including warning and caution statements, is similar to that informaticate devices. The addition of this new feature does not raise new questions of safety or effectiveness for the Esprit.
Summary of Performance Testing: 6.5
Safety testing was conducted per the applicable sections of IEC 60601-1-2 and UL 2601. Software validation testing was performed in accordance with FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998). The results of all verification and validation testing demonstrate that all design and system requirements for the Esprit ventilator with NICO-Esprit Interface have been met.
Conclusion: 6.6
The technological characteristics of the Esprit ventilator with NICO-Esprit Interface and the results of the performance testing do not raise new questions of safety and effectiveness and demonstrate that the device is substantially equivalent to the legally marketed predicate devices.
2
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three overlapping lines forming the wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 8 2004
Ms. Mary Funk Regulatory Affairs Project Manager Respironics California, Incorporated 2271 Cosmos Court Carlsbad, California 92009
Re: K041412
Ko41412
Trade/Device Name: Esprit Ventilator with NICO-Esprit Interface Option, Model V1000 Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 26, 2004 Received: May 27, 2004
Dear Ms. Funk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for the sured in the May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmette For (110) that the device, subject to the general controls provisions of the Act. The 1 ou may, aters, provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it n your de vice to such additional controls. Existing major regulations affecting your device can may be subject to back as a sateral Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that I'DA's issuance of a substantial equivalence determination does not mean r rease be act nou mail termination that your device complies with other requirements of the Act that + Drimas intatutes and regulations administered by other Federal agencies. You must
3
Page 2 – Ms. Mary Funk
comply with all the Act's requirements, including, but not limited to: registration and listing (21 comply with all the Act 3 requirements, niems manufacturing practice requirements as set
CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice the electronic CFR Part 807); labeling (21 CFR Part 017), good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Part 820); and if app 1000, 1050 - This forth in the quality systems (QS) regulation (21-542 of the Act); 21 CFR 1000-1050. This product radiation confor provisions (Sections For Sections of Section 510(k) letter will anow you to begin marketing your substantial equivalence of your device to a legally premarket notification. The FDA miding of dassification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific advice for your ac not on one on one one the regulation entitled,
contact the Office of Compliance at (301) 594-4646. Also, please note Contact the Office of Comphance at (So Frenarket notification" (21CFR Part 807.97). You may obtain "Misbranding by relevelec to premanter notifications in the Act from the Division of Small other general Information on your responsion.com at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Special 510(k): Device Modification Esprit Ventilator with NICO-Esprit Interface
STATEMENT OF INDICATIONS FOR USE 8
Koy1412-510(k) Number (if known):
Esprit Ventilator with NICO Esprit Interface Device Name:
The Esprit ventilator is a microprocessor controlled, electrically Indications for use: The Eoph vechanical ventilator. It is intended for use by powered, moonanisal personnel in providing continuous or qualificu - modioa. Support for adult and pediatric patients intermittent vontilatory sician. The Esprit Ventilator is intended for use in either invasive or non-invasive applications.
Prescription Use XX (Per 21 CFR 801 subpart D) AND/OR
Over-the-counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hna U. Pinto
Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number _
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